Intravenous Catheter Insertion And Blood Sample Devices And Method Of Use

ABSTRACT

A catheter insertion device includes a housing, a needle, a catheter, and a guide wire. The needle has a proximal end positioned in the housing and a distal end extending beyond a distal end of the housing. The catheter is positioned coaxially over the needle, and includes a flexible tube and a catheter hub on a proximal end of the flexible tube. A proximal portion of the flexible tube and the catheter hub are positioned in the housing. the guide wire has a proximal end positioned in the housing and a distal end positioned in a lumen of the needle. The catheter insertion device also includes a handle coupled to the catheter, wherein movement of the handle relative to the housing moves the catheter hub from a position in the housing to a position outside of the housing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/174,071, filed Feb. 6, 2014, which is a continuation of U.S. patentapplication Ser. No. 12/598,053, filed Apr. 20, 2010, now U.S. Pat. No.8,721,546, which is a U.S. National Stage Application of InternationalPatent Application No. PCT/US2008/062954, filed May 7, 2008, whichclaims priority to U.S. Provisional Application Nos. 60/916,552 and60/916,553, both filed May 7, 2007, the full disclosures of which areincorporated herein by reference in their entirety.

International Patent Application No. PCT/US2008/026954 is related toU.S. patent application Ser. No. 11/577,491 filed on Apr. 18, 2007, andInternational Patent Application No. PCT/US2007/68393, filed on May 7,2007.

BACKGROUND OF THE INVENTION 1. Field of the Invention

Catheter insertion and blood collection are two activities that areoften made more difficult in patients with small or collapsed vessels orwith other conditions that complicate insertion of a device into thepatient's vessels. In other cases, the insertion of a catheter orpreparations for blood collection may be simplified in order to allowfor automation of all or a part of the insertion or blood draw process.As such, a need remains for improved devices and methods for catheterplacement and blood collection.

SUMMARY OF THE INVENTION

In one embodiment, there is provided method of introducing a catheterinto a vessel in a patient. The method includes the steps of: insertinga needle into the vessel until a bleed back indication is provided;advancing a guide wire through the needle and into the vessel;activating a catheter advancement device; and propelling the catheterwith the catheter advancement device to move along the guide wire andinto the vessel. In one aspect, the activating step is performedmanually by a user. In another aspect, the propelling step also includespropelling the catheter out of a housing that contains the guide wire.In alternative aspects, the bleed back indication is a visual indicationsuch as a light. In another alternative aspect, the bleed backindication is an audible indication.

In another alternative aspect, the bleed back indication is provided asa signal produced by a bleed back sensor in communication with theneedle. Alternatively, the bleed back sensor in communication with theneedle is inside a housing containing a portion of the guidewire.Optionally, the signal initiates the activating a catheter advancementdevice step. In other aspects, the method of introducing a catheter intoa vessel also includes retracting the needle and the guide wirecompletely into a housing after the propelling step. In other aspects,the method of introducing a catheter into a vessel also includesretracting the needle completely into a housing while retracting all butthe distal end of the guide wire into the housing, after the propellingstep. In other aspects, the retracting all but the distal end of theguide wire is provided by an obstruction. The obstruction may bepositioned inside the housing and include a fracture able component.

In other aspects, the method of introducing a catheter into a vesselalso includes stopping the propelling step when an insertion resistancedetector indicates that a detected resistance to catheter advancementexceeds an allowable limit. Optionally, the method includes stopping thepropelling step when a resistance to catheter advancement is greaterthan a force used to propel the catheter. In other alternatives, theforce used to propel the catheter is a spring force, a pneumatic force,a force generated by a motor or a force generated by the movement oractivation of a shape memory alloy element.

In another alternative embodiment, there is provided a method ofintroducing a catheter into a vessel in a patient with the steps ofinserting a needle into the vessel until a bleed back indication isprovided; activating a guide wire advancement device; propelling a guidewire through the needle and into the vessel; and advancing a catheteralong the guide wire and into the vessel. And an additional aspect, thepropelling step also includes propelling the guide wire out of a housingthat contains a portion of the needle. In one aspect, the bleed backindication is a visual indication, and may be a light. In anotheraspect, the bleed back indication is an audible indication. In otherconfigurations, the bleed back indication is provided as a signalproduced by a bleed back sensor in communication with the needle. In oneaspect, the bleed back sensor in communication with the needle is insidea housing containing a portion of the guidewire. In another aspect, thesignal initiates the activating a guide wire advancement device step.

The method of introducing a catheter into a vessel may also include thestep retracting the needle and the guide wire completely into a housingafter the propelling step. Additionally, the method of introducing acatheter into a vessel may include the step of retracting the needlecompletely into a housing while retracting all but the distal end of theguide wire into the housing, after the propelling step. Additionally,the method may include the step of stopping the propelling step when aninsertion resistance detector indicates that a detected resistance toguide wire advancement exceeds an allowable limit. In one aspect, themethod includes the step of stopping the propelling step when aresistance to guide wire advancement is greater than a force used topropel the guide wire. An additional aspects and alternatives, themethods and devices used for device insertion or blood collection may beconfigured to use any combination of one or more forces to propel theguide wire and/or the catheter using a spring force, a pneumatic force,a force generated by a motor, a force generated by the movement oractivation of a shape memory alloy element, or a magnetic force.

In another embodiment, there is provided an intravenous catheterinsertion device. In one aspect, the intravenous catheter insertiondevice includes a housing having an interior space, a proximal end and adistal end defining a housing length there between. An access needlehaving a lumen, the access needle positioned within the interior spacesuch that a distal end of the needle extends beyond the housing distalend. An intravenous catheter having a proximal end and a distal end, ahub on the proximal end and a lumen extending through the hub to thedistal end, the intravenous catheter positioned within the housingdistal end with the intravenous catheter lumen over the access needle. Aguide wire within the interior space and the access needle lumen. Thereis also provided a catheter advancement device on the housing coupled tothe catheter such that operation of the catheter advancement devicemoves the catheter relative to the access needle. In another aspect, theintravenous catheter insertion device includes a bleed back sensor incommunication with the needle lumen. The bleed back sensor may bemounted on the housing or within the interior space. There may also be alight coupled to the bleed back sensor wherein the light illuminateswhen the bleed back sensor is activated. There may also be a device foremitting an audible indication coupled to the bleed back sensor whereinthe device emits an audible indication when the bleed back sensor isactivated. In one aspect, the bleed back sensor produces a signal thatactivates the catheter advancement device. In one configuration, thecatheter advancement device is configured to use a force generated by aspring to move the intravenous catheter relative to the access needle.In another configuration, the catheter advancement device is configuredto use a force generated by a pneumatic actuator to move the intravenouscatheter relative to the access needle. In another configuration, thecatheter advancement device is configured to use a force generated by amotor to move the intravenous catheter relative to the access needle. Inanother configuration, the catheter advancement device is configured touse a force generated by a shape memory alloy element to move theintravenous catheter relative to the access needle.

In other configurations, the intravenous catheter insertion deviceincludes a resistance detector configured to stop the operation of thecatheter advancement device when a detected resistance exceeds anallowable limit. In some configurations, the allowable limit is relatedto the resistance of an unobstructed catheter advancing along a guidewire. In other configurations, the allowable limit is related to theresistance of an unobstructed catheter advancing through the lumen of ablood vessel.

In one aspect, the intravenous catheter insertion device has an interiorspace is dimensioned to store the access needle and the guide wire afteruse. In one configuration the intravenous catheter insertion device, adistal end of the guide wire is visible in the housing after use. In onealternative, a view port or window is provided in the housing thatpermits inspection of the guide wire tip. In one configuration,operation of the catheter advancement device is initiated by a user. Inother aspects, an insertion resistance detector adapted to monitor theoperation of the catheter advancement device and/or a guide wireinsertion device, depending upon device configuration. In oneconfiguration of an intravenous catheter insertion device there is anotch in the housing shaped to prevent the withdrawal of the guide wireor needle into the housing. In a variation of this configuration, theintravenous catheter insertion device includes a by pass around thenotch in the housing that allows the withdrawal of the guide wire orneedle into the housing. In still other configurations, the intravenouscatheter insertion device has a stop within the housing shaped toprevent the withdrawal of the guide wire tip into the housing andfacilitate inspection of the guide wire tip.

In another embodiment, there is an intravenous catheter insertion devicethat includes a housing having an interior space, a proximal end and adistal end defining a housing length there between. There is also anaccess needle having a lumen, the access needle positioned within theinterior space such that a distal end of the needle extends beyond thehousing distal end. There is also an intravenous catheter that has aproximal end and a distal end, a hub on the proximal end and a lumenextending through the hub to the distal end. The intravenous catheter ispositioned within the housing distal end with the intravenous catheterlumen over the access needle. There is also a guide wire within theinterior space and the access needle lumen. A guide wire advancementdevice coupled to the guide wire such that operation of the guide wireadvancement device moves the guide wire relative to the access needlelumen.

In one alternative, the intravenous catheter insertion device includes ableed back sensor in communication with the needle lumen. The bleed backsensor may be mounted on the housing. The bleed back sensor may bewithin the interior space. Additionally, a light coupled to the bleedback sensor wherein the light illuminates when the bleed back sensor isactivated. Additionally, a device for emitting an audible indicationcoupled to the bleed back sensor wherein the device emits an audibleindication when the bleed back sensor is activated. In one aspect, thebleed back sensor produces a signal that activates the guide wireadvancement device. In another aspect, the guide wire advancement deviceis configured to move the guide wire relative to the access needle lumenusing a force generated by a spring, a pneumatic actuator, a motor,and/or the movement or actuation of a shape memory alloy component.Additionally, the intravenous catheter insertion device also includes aresistance detector configured to stop the operation of the guide wireadvancement device when a detected resistance exceeds an allowablelimit. In one alternative, the allowable limit is related to theresistance of an unobstructed guide wire advancing through the lumen ofan access needle. In another alternative, the allowable limit is relatedto the resistance of an unobstructed guide wire advancing through thelumen of a blood vessel. In one aspect, the interior space intravenouscatheter insertion device is dimensioned to store the access needle andthe guide wire after use. In one aspect, the distal end of the guidewire is visible in the housing after use. In one aspect, the operationof the guide wire advancement device is initiated by a user. In anotheralternative, an insertion resistance detector is positioned on or in thedevice housing and is adapted to monitor the operation of the guide wireadvancement device. Similarly, such a resistance detector may bepositioned on or in the device housing and adapted to monitor theoperation of the catheter advancement device.

In another embodiment, there is provided an apparatus for drawing blood.The apparatus includes a housing having a proximal end, a distal end andan interior volume. A seal is positioned within the housing partitioningthe interior volume into a first interior volume portion and a secondinterior volume portion. A housing lumen is provided that extends fromthe housing distal end and is in communication with the first interiorvolume portion. There is a blood draw port on the housing incommunication with the first interior volume portion. An access needleis provided that extends through the housing lumen. The access needlehaving has an access needle lumen, a distal end that extends beyond thehousing distal end, and a proximal end within the second interior volumeportion. There is a guidewire within the access needle lumen. In onealternative, the blood draw device includes a flexible tube positionedaround the housing lumen and sized for insertion into a blood vessel.Optionally, the flexible tube is part of or is an intravenous catheter.The blood draw device may also include a nose section on the housingdistal end positioned around the housing lumen.

The blood draw device may also have specific dimensions, such as, forexample, a longitudinal length of the second interior volume portion issufficient to allow movement of the access needle from a first positionwherein only the access needle proximal end is within the secondinterior volume portion and a second position wherein both the accessneedle proximal portion and distal portion are within the secondinterior volume portion. Other dimensions include a flexible tube thatis sufficiently long to maintain an overlapping region about the housinglumen while the flexible tube is inserted into a blood vessel.Additionally, the needle distal end extends beyond the distal end of theflexible tube. In another aspect, the needle distal end extends beyondthe distal end of the nose section of the housing. In one embodiment,the needle distal end extends from 1 mm to 10 mm beyond the flexibletube. In still another embodiment, the needle distal end extends from 1mm to 10 mm beyond the distal end of the nose section.

In another aspect of an insertion device, there is provided a slot inthe housing and a handle within the slot coupled to the guidewirewherein movement of the handle along the slot moves the guidewirerelative to the access needle lumen. Additionally, an insertion devicemay include a mechanism in the housing coupled to the needle and theguide wire to retract the needle and the guide wire into the secondinterior volume portion proximal to the seal. In another aspect, andinsertion device may include a biasing element that when releasedwithdraws one or both of the access needle and the guide wire into thesecond interior volume portion. In another aspect of and insertiondevice, when the biasing element is released, the access needle iswithdrawn completely into the second interior volume portion and theguide wire distal end is visible in the first interior volume portion.In another aspect of an insertion device, when the biasing element isreleased the guidewire and the needle are removed from the housing lumenand the first interior volume portion. In another aspect of an insertiondevice, the distal end of the guidewire is curved when unconstrained bythe access needle lumen.

In one aspect of a blood draw device, the blood draw port has a hollowmember configured to penetrate a seal on a blood draw container. Inanother aspect, the blood draw port also includes a fitting having alumen in communication with the first interior volume portion. Inanother aspect of the blood draw device, the flexible tube is attachedto a hub.

In another aspect of the blood draw device, the seal is configured toform a seal around the guide wire when the guide wire is in the firstinterior volume portion and the access needle is completely within thesecond interior volume portion. In another aspect, the seal isconfigured to form a seal around the access needle while the accessneedle is within the first interior volume portion. In another aspect,the seal partitions the interior volume so as to substantially separatethe first interior volume portion from the second interior volumeportion. In another aspect, the seal partitions the interior volume butallows communication between the first interior volume portion and thesecond interior volume portion.

In one exemplary embodiment there is provided a method for drawing bloodfrom a patient. The exemplary method includes the step of inserting anaccess needle into a vessel of the patient wherein a lumen of the accessneedle is in communication with an interior volume of a housing on oneside of a seal within the housing that partitions the interior volume ofthe housing into a first interior volume portion and a second interiorvolume portion. Next, there is the step of advancing a guidewire thoughthe access needle lumen and into the vessel. Next, there is the step ofadvancing a flexible tube along the guide wire and into the vessel.Next, there is the step of withdrawing the access needle into the secondinterior volume portion to place the flexible tube in communication witha blood draw port in the first interior volume portion. Finally, thereis the step of withdrawing a blood sample from the vessel through theblood port.

In one aspect, the method of withdrawing blood from a patient alsoincludes withdrawing the guidewire from the vessel and into a positionwhere a distal end of the guide wire is visible to a user. In anotheraspect, the method of withdrawing blood from a patient includeswithdrawing the guidewire from the vessel before, during or after thewithdrawing the access needle step. In another aspect, the withdrawingthe guide wire step and the withdrawing the access needle step areperformed manually by a user. In still another aspect, one or both ofthe withdrawing the guide wire step and the withdrawing the accessneedle step are performed by releasing a biasing element. An alternativemethod, after the withdrawing the guidewire step and the withdrawing theaccess needle step, one or both of the access needle and the guidewireare within the second interior volume portion. In additional aspects,there is also the step of withdrawing the flexible tube from the vesselafter the withdrawing a blood sample step. In other aspects, the methodincludes the step of disconnecting the flexible tube from the housingafter the withdrawing a blood sample step while maintaining the flexibletube in the vessel. In still other aspects, the method includes the stepof securing the flexible tube to the patient while maintaining theflexible tube in the vessel.

While some aspects of the invention are described in relation to theadvancement or retraction of a guide wire, those aspects may also beapplied to a catheter and needle. Similarly, those aspects described forcatheter and needles may also be applied to guide wires and the othercomponent as well.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a section view of an intravenous catheter insertion devicehaving only the distal end of the access needle extending beyond thehousing distal end;

FIG. 2 is a flow chart of a catheter insertion technique using thedevice of FIG. 1;

FIG. 3 is a schematic view of an intravenous catheter insertion devicehaving one or more additional blood detection capabilities;

FIG. 4 illustrates schematically several event sequences for deviceinsertion utilizing blood sensing and detection capabilities includingthe use of blood detection within an automated insertion device based ona detected signal;

FIG. 5 is a flow chart for a catheter insertion technique using eithermanual or automated steps for catheter insertion device operation;

FIGS. 6 and 7 illustrate alternative positions for blood detectionsensors in an access needle;

FIG. 8 is a flow chart of using a catheter insertion device having bloodsensing or vessel access indication capabilities and optional automatedwithdrawal capabilities and optional guide wire inspection capabilities;

FIG. 9 is a section view of an intravenous catheter insertion devicesimilar to the device of FIG. 1 with additional blood sensing andindication capabilities. FIG. 9A is a detailed view of the distal tip ofthe catheter of FIG. 9;

FIGS. 10 and 10A illustrate the device of FIG. 9 during needle insertionand blood detection;

FIG. 11 illustrates the device of FIG. 9 during advancement of the guidewire into a vessel;

FIG. 12 illustrates the device of FIG. 9 during advancement of acatheter out of the housing an into the vessel over the guide wire aspositioned in FIG. 11;

FIG. 13 illustrates the device of FIG. 9 after automatic withdrawal ofthe needle and guide wire from the position in FIG. 12;

FIG. 14 illustrates an inserted catheter;

FIG. 15 is a section view of a intravenous catheter insertion devicesimilar to the devices in FIGS. 9 and 1 with the addition of a guidewire advancement mechanism and a catheter advancement mechanism;

FIG. 16 illustrates the device of FIG. 15 during needle insertion andblood detection;

FIG. 17 illustrates the device as positioned in FIG. 16 after guide wireadvancement into a vessel using the guide wire advancement device;

FIG. 18 illustrates the device as positioned in FIG. 17 afteradvancement of a catheter out of the housing an into the vessel usingthe catheter advancement device;

FIG. 19 illustrates the device as positioned in FIG. 18 after automaticwithdrawal of the needle and guide wire from the vessel and catheter;

FIGS. 20A and 20B illustrate a pneumatically activated guide wireinsertion device before activation (FIG. 20A) and after activation (FIG.20B);

FIGS. 21A and 21B illustrate a pneumatically activated guide wireinsertion device with a flow restrictor or flap before activation (FIG.21A) and after activation (FIG. 21B);

FIGS. 22A and 22B illustrate a shape memory alloy (SMA) activated guidewire insertion device before activation (FIG. 22A) and after activation(FIG. 22B);

FIG. 23A shows a section view of an intravenous catheter insertiondevice similar to the device of FIG. 9 with blood draw capabilities anda manual catheter insertion capability;

FIG. 23B is an end view of the device of FIG. 23A;

FIGS. 24A and 24B illustrate the device of FIG. 23A during needleinsertion and blood detection;

FIG. 25 illustrates the device as positioned in FIG. 24A afteradvancement of the guide wire into a vessel;

FIG. 26 illustrates the device as positioned in FIG. 25 after manualadvancement of a catheter out of the housing and into the vessel overthe guide wire;

FIG. 27 illustrates the device of FIG. 26 after automatic withdrawal ofthe needle and guide wire into the housing to allow fluid communicationfrom the vessel to the blood draw port and inspection of the guide wiretip in a tip view window;

FIG. 28A illustrates an inserted blood draw device as positioned in FIG.27 in use to draw blood samples;

FIGS. 28A through 28C illustrate section views of distally andproximally oriented seal closure designs, respectively;

FIGS. 29A-33B illustrate alternative seal designs for use in the blooddraw device to partition the interior volume of the blood draw device;

FIG. 34 is a section view of an intravenous catheter insertion devicesimilar to the device of FIG. 23A with blood draw capabilities and onlycapabilities for catheter and guide wire insertion and withdrawal;

FIG. 35 illustrates a section view of alternative blood sample port thatmay be penetrated by a sample needle;

FIG. 36 is a section view of a blood sample port connected to a flexiblecollection tube and an exemplary blood collection device;

FIG. 37A shows a section view of an intravenous catheter insertiondevice with blood draw capabilities similar to the device of FIG. 23Awith outer and inner flexible tubes to provide blood draw capabilities.The device is inserted into a vessel and indicating blood detection asin FIG. 24A;

FIG. 37B is an end view of the device of FIG. 37A;

FIG. 38 illustrates the device as positioned in FIG. 37A afteradvancement of the guide wire into a vessel;

FIG. 39 illustrates the device as positioned in FIG. 38 after manualadvancement of the outer flexible tubing along the inner flexible tubingand into the vessel over the guide wire;

FIG. 40 illustrates the device as positioned in FIG. 39 after automaticwithdrawal of the needle and guide wire into the housing to allow fluidcommunication from the vessel to the blood draw port and inspection ofthe guide wire tip in a tip view window. The figure also illustratesfluid communication from the vessel to the blood draw port using theinner and outer flexible tubes;

FIG. 41 illustrates an inserted blood draw device as positioned in FIG.40 in use to draw blood samples;

FIG. 42 illustrates the outer flexible tube in place and providingaccess to the vessel as in FIG. 41 after removal of the housing;

FIG. 43A-43C are isometric views of an insertion device with guide wiretip inspection capabilities where FIG. 43A is a view of the needle andguide wire prior to withdrawal;

FIG. 43B is an isometric view of the device in FIG. 43A after partialwithdrawal of the guide wire handle to a notch that positions the guidewire tip for inspection;

FIG. 43C is an isometric view of the device of FIG. 43B after the guidewire handle has been moved to by pass the notch position shown in FIG.43B and provide complete guide wire withdrawal into the housing;

FIGS. 44A-44F illustrate the operation of a insertion device with amanual stop to allow for guide wire inspection after use;

FIG. 44A is a section view of an insertion device after catheteradvancement and prior to guide wire and needle retraction;

FIG. 44B is a section view of the device as positioned in FIG. 44A afterretraction of the needle and guide wire to a first mechanical stop;

FIG. 44C is a section view of the device as positioned in FIG. 44B afterseparation of the catheter from the insertion device;

FIG. 44D is a bottom up view of the device in FIG. 44C with the guidewire visible in the housing;

FIG. 44E is a section view of the device as positioned in FIG. 44C afterthe continued withdrawal of the guide wire handle beyond the mechanicalstop to a position where the guide wire and the needle are completelywithin the device housing;

FIG. 44F is a bottom up view of the distal end of the housing of thedevice as positioned in FIG. 44E showing that the guide wire is nolonger within the device housing distal end.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a section view of an intravenous catheter insertion device1 according to one embodiment the present invention. Insertion device 1includes an insertion device housing 5 having a proximal end 6, a distalend 7 and an interior space 9. A slot 8 is provided in the distal end 7to allow movement of the catheter hub 45 along the interior space 9. Theguide wire 10 has a distal end 11, a proximal end 12 and a guide wiretip 13. The guide wire tip 13 may be straight, coiled, curved or in anyof a number of shapes to allow for atraumatic insertion into andtranslation along a vessel. There is also a guide wire advancement lever14 and a guide wire carrier 15. The guide wire 10 is attached to theguide wire carrier 15 and moveable relative using the guide wireadvancement level 14. There is also an access needle 20 having a distalend 21, a proximal end 22 and an access needle lumen 23. The accessneedle 20 is contained within a needle carrier 25. The needle carrierincludes a boss 24 positioned to engage with other components in thedevice 1 such as the release lever 31. A biasing element is shown on theneedle carrier 25. The release lever 31 holds the needle carrier inplace with the biasing element 33 in a compressed configuration. Whenthe release button 30 is depressed, the release lever 31 tips upallowing the biasing element 33 to expand and move the needle carrierand the guide wire carrier in a proximal direction. The movement of theexpansion element causes proximal movement of the guide wire and needlecarriers that will in turn withdraw the needle and guide wire from avessel.

FIG. 1 also illustrates a conventional intravenous catheter 40. Theintravenous catheter 40 has a proximal end 41 and a distal end 42. Thecatheter includes a hub 45 on the proximal end attached to a flexibletube or cannula 44 that extends to the distal end 42. A lumen 44 extendsfrom the proximal end 41 to the distal end 42 through the hub 45 and theflexible tube or cannula 43.

In the embodiment of FIG. 1, the housing 5 and interior section 8 are sodimensioned that some or the entire catheter 40 is also positioned inthe housing 5. In contrast to other catheter insertion deviceembodiments where the catheter extends completely external to thehousing distal end and the needle within it, here the catheter 40 andmost of the needle 20 are stowed within the housing 5. As a result,instead of a patient seeing a full length needle extending along andthrough a catheter or protruding from the end of the housing, thepatient only sees the tip of the needle 20 extending from the distal endof the housing 5 as shown in FIG. 1.

In some embodiments, some portion of the catheter flexible tube orcannula 43 may also be visible beyond the housing distal end 7.Operation of the device 1 is straightforward. After the needle 20 hasbeen inserted into a vessel, the guide wire 10 is advanced into thevessel by distal movement of the guide wire knob 14. Once the guide wire10 is extended into the vessel, the catheter 40 is advanced out of thehousing 5 and into the vessel using the catheter knob (if provided as inFIG. 23A) or by simply grasping the catheter hub 45 and advancing thecatheter 40 into the vessel. Thereafter, the release button 30 is usedto initiate a withdrawal sequence to move both the guide wire 10 and theneedle 20 to a position completely within the housing 5. The device andtechnique described herein could be used to place a flexible catheterinto a vessel. Additionally or alternatively, once the flexible catheteris in position in the vessel, the flexible catheter is used for bloodsample collection.

FIG. 2 shows a flow chart of a catheter insertion technique using thedevice of FIG. 1. The device 1 is a so called short needle devicebecause only a small amount of the needle is visible to the patient fromthe housing distal end. First, at step 205, the short needle is visiblefrom the distal end of the housing. Next, step 210, the short needle isused to puncture the target vessel. The amount of the needle extendingfrom the distal end of the housing is sufficient to perform the vesselpuncture step. A conventional venipuncture needle may be used but thelength of the needle is retained inside of the housing out of view fromthe patient. An exemplary puncture step, similar to that used by device1, is shown in FIG. 10. Next, at step 215, the guide wire 10 is advancedthrough the needle 20 into the vessel. Here the guide wire advancementlever 14 is moved distally and the guide wire 10 is moved relative tothe access needle lumen 23. Exemplary guide wire advancement similar tothat used by device 1 is illustrated in FIG. 11.

Next, at step 220, the catheter 40 is advanced using the catheter knob(if provided) out of the housing 5 and into the vessel following alongthe guide wire 10. Exemplary catheter advancement, similar to that usedfor device 1, is shown in FIG. 12. Next, step 225, a guide wire andneedle withdrawal sequence is initialed using an automatic (depressrelease button 30 in FIG. 1) or by manual withdrawal (see FIG. 34).

Finally, step 230, the guide wire 10 and the needle 20 are completelywithin the housing 5 and the catheter 40 is within a vessel. The finalposition of the components of device 1 after performing the method 200are similar to that illustrated in FIGS. 13 and 14.

FIG. 3 shows a schematic view of an intravenous catheter insertiondevice 700 according to one embodiment the present invention. Sensorscan be included in the insertion device or aspects of the insertionprocess can be automated as will be further described below.

The catheter insertion device 700 includes an access needle 720, a blooddetection sensor 702, a housing 705, a sensing system for blooddetection 710, a guidewire/needle refraction system 725, a guide wirestorage area 730 and an in handle storage area 740 for storage ofcontaminated components. As will be understood from the embodiments thatfollow, many of the components illustrated in the schematic insertiondevice 700 may optionally be removed from an insertion device embodimentdepending upon the desired functionality of the insertion device. Forexample, an insertion device 1 (FIG. 1) may omit the blood detection 702and sensing system 710. The insertion device 1 a may include the bloodsensing capabilities omitted by insertion device 1 and so on.Additionally, a device 700 may have a retraction system 725 that isautomatic as in FIG. 1 or manual as in FIG. 34.

The housing 705 contains a number of components to automate some of thesteps used for catheter insertion. A needle 720 is used to accessvessel. A blood detection sensor or sensors 702 are provided. The blooddetection sensor 702 may be needle based as illustrated or otherwiselocated within the housing 705. The blood detection sensor 702 providesinformation to a sensing system for blood detection 710. The sensingsystem 710 interprets the signal produces by the blood detection sensor702 and provides indications or triggers for other actions in theinsertion process. An indication may be a signal perceptible by a userto indicate that blood is detected. A trigger may be any form of machinerecognizable signaling that used by another part of the insertion device700 to initiate a process or activate a component. Optionally, thedevice 700 may also include guide wire storage 730 within the housing705 as well as adequate storage 740 for contaminated components. In manyembodiments, the storage requirements for 730, 740 are sized andpositioned in the housing 705 to allow for storage of the needle andguidewire used during the insertion process.

Either or both of the guide wire and access needle used in the system700 may be adapted and configured for automatic or assisted insertion orretraction as described in the detailed examples that follow.Additionally, an intravenous catheter may optionally be configured forautomatic insertion as described below. The guide wire storage 730ensures that adequate guide wire is contained in the system for accessto a wide variety of vessels including central veins. In one aspect,when the needle enters a vessel the blood detection sensors (FIGS. 6, 7,9, 10A, 15, 24A and 37A) used in conjunction with electronic componentsand programming in the sensing system for blood detection may be used toprovide an indication of bleed back to a user or to provide a triggersignal for some other part of the system to initiate a sequence (FIGS.4, 5 and 8). The guide wire and/or needle retraction system includesmanual and/or automatic withdrawal devices to pulling the needle andguide wire completely into the housing after use so that no sharps orblood contaminated components remain outside of the housing after use.

FIG. 4 provides an overview of possible techniques of how sensors andautomation may be used. Two blood detection sensors 50 are illustratedon an access needle 20. The blood detection sensors 50 are incommunication with a suitable bleed back sensor, circuit or electroniccontroller 600 for translating the detection signal from the sensor 50into a signal usable by the blood detection system. While FIG. 4provides an exemplary embodiment with two needle based blood sensors 50,other configurations are possible. For example, only one needle basedsensor 50 is used. Alternatively, one bleed back sensor 50 could be usedfor triggering an event or action in the system (via the sensor circuit600) and another bleed back sensor could take the form an opening thatprovides a visual indication of bleed back to a user. In otheralternatives, the blood sensor 50 is located in a position other than inthe needle 20. The bleed back sensor 50 is positioned within the housingvolume or in communication with blood elsewhere on the device.

One sequence of events illustrated in FIG. 4 is the automated insertiondevice based on a detected signal. In this alternative, a signal fromthe bleed back or blood detection circuits 600 may be used in a numberof ways. The signal produced by bleed back sensors/circuits 600 may beused to initiate an automatic or assisted sequence 605. The automatedsequence 605 may include all or some of the steps in the method 150(FIG. 5).

In another possible sequence, the signal from the bleed back detectioncircuit 600 may be used to trigger auto-advance the guide wire 610. Thisstep may be as described in step 130 of FIG. 5 or as described below inthe automatic guidewire devices that follow.

In another alternative, the bleed back signal from the bleed backcircuit 600 may provide an audible (620) or visible (615) indicationthat manual or automatic guide wire insertion or catheter insertion maybegin or resume.

FIG. 5 illustrates a method 105 having the basic steps for insertionsequence including possible automation for the process. The flow chart105 describes a catheter insertion technique using a manual and/orautomated catheter insertion techniques or devices. FIG. 5 shows a flowchart of an insertion technique 105 that may be partially or completelyautomated or provide assistance to a user. First, at step 110, locatethe vein or vessel to access. Next, step 120, use needle to puncture thevessel until bleed back is (a) visible or (b) indicated by the systemusing the sensors. Next, step 130, the guide wire is advanced throughthe needle into the vessel. The guide wire is advanced into the vesselsufficiently far to ensure sufficient catheter guidance. Next, step 140,the catheter is advanced manually with assistance from the system orautomatically using the system. Next, step 150, a guide wire and needlewithdrawal sequence is initialed using an automatic or by manualwithdrawal. Finally, step 230, the guide wire and the needle arecompletely within the housing and the catheter is secured to thepatient.

In various alternative embodiments, one or more of the steps 130, 140and 150 are adapted for automatic or assisted operation using thesystems described herein.

FIGS. 6 and 7 illustrate alternative positions for detection circuits orsensors 50 on an access needle 20. The access needle 20 has a distal end21 and a lumen 23. The sensors may be within the lumen 23 or on theneedle and in communication with the lumen 23 via a small port (notshown).

FIG. 8 is a flow chart 300 showing the steps of a catheter insertionprocess that incorporates one or more of bleed back sensing; automaticguidewire/needle withdrawal and guide wire tip inspection. It is to beappreciated that the steps of method 105 (FIG. 5) may also be includedinto the flow chart 300. In particular, some of the steps in method 300may be automated according to the description of method 105 or otherembodiments that follow that include one or both of assisted guidewireadvancement and assisted catheter advancement. The insertion device 1 aof FIGS. 9-14 will be discussed in relation to the exemplary insertionprocess set out in the steps of flow chart 300.

FIG. 9 shows a section view of an intravenous catheter insertion device1 a according to one embodiment the present invention. Device 1 a issimilar to the insertion device 1 with the addition of blood detectioncapabilities. The blood detection sensor 50 is located within thehousing 5 in communication with the access needle lumen 23. A blooddetection indicator 51 is in communication with the blood detectionsensor 50.

FIG. 9A is an end view of the distal end 7 of the insertion device 1 a.The slot 8 provides access for the catheter hub 45 to slide through thedistal end 7 as the catheter hub 45 is advanced out of the device distalend and into the vessel 3 (step 340).

Similar to device 1 in FIG. 1, FIG. 9 illustrates an embodiment of adevice 1 a having a housing 5 and interior section 9 are so dimensionedthat the catheter 40 is also positioned in the housing 5. In contrast toother embodiments where the catheter extends completely external to thehousing distal end and the needle within it, the catheter and most allof the needle are stowed within the housing. As best seen in FIGS. 9 and10, the needle distal end 21 extends just beyond the housing distal end7. As a result, instead of a patient seeing almost an entire needleextending along and through a catheter hub, the patient only sees thetip of the needle extending from the distal end 7 of the housing 5. Insome embodiments, some portion of the catheter lumen (such as the distalend 42) may also be visible beyond the housing distal end 7 (see FIG.9). Alternatively, the catheter distal end 42 may be proximal to thehousing distal end 7 as shown in FIG. 10. After the needle 20 has beeninserted, the guide wire 10 is advanced by moving the guide wire knob14. Once the guide wire 10 is extended into the vessel 3, the catheter40 is advanced out of the housing 5 and into the vessel 3 using, forexample, a re-useable catheter advancement device described below.

As described below in the embodiment of FIG. 15, a catheter advancementmotor or drive may be used to propel the catheter out of the housing topropel a length of catheter lumen or other flexible medical grade linefrom storage along the guide wire and into a vessel. In someembodiments, an insertion resistance detector monitors the catheteradvancement device and/or the flexible tubing for indications thatresistance in the vessel is outside of allowable limits for catheteradvancement. One instance when resistance may exceed limits is if thecatheter is advanced into a vessel wall or other obstruction. Ifinsertion resistance is detected, then the system may stop theadvancement device and/or provide an alarm to the user.

Once the automated catheter insertion sequence is completed, the releasebutton 30 is used to initiate a withdrawal sequence to move both theguide wire 10 and the needle 20 completely within the housing.Optionally, the useable catheter insertion device may them be sterilizedas needed and another catheter loaded into the catheter advancementhousing. Then, the catheter advancement housing is loaded onto thedistal end of the housing and the needle inserted into the catheter intothe position illustrated in FIG. 9. The device is ready for anotherinsertion sequence.

Returning now to the method of FIG. 8 and the device 1 a in FIG. 9.First, according to step 310, insert a needle into a vessel. FIG. 10illustrates the movement of the components of the embodiment of FIG. 9as an example of how this step of the method may be accomplished.

Next according to step 320, sense/indicate vessel access. This step isincludes the detection of bleed back and may include some or all of theaspects described above in relation to FIG. 4. FIG. 10A is a close up ofthe view illustrated in FIG. 10. FIG. 10A illustrates a sensor 50 incommunication with the access needle lumen 23. Blood 4 has advanced upthe needle lumen 23 into contact with the sensor 50. As a result, theindicator 51 is triggered to show that bleed back is present. In theillustrated embodiment, the indicator is a light or light emitting diode(LED).

Bleed back is a common indication of the needle tip entering the targetvessel and blood coming into the needle and becoming visible to theuser. While the user may also perceive the bleed back indication,embodiments of the present invention also can be used to detect,indicate or trigger actions based on bleed back. It is to be appreciatedthat any of a wide variety of signals and detection techniques can beused to determine whether blood has entered the needle. These range fromthe visual indication of blood in the needle or housing. The detectionof blood may also be provided by a blood detecting sensor. Additionally,the detection of blood could be performed by any type of signaling ordetection technique to identify the passage of blood though the needleor to indicate that the needle has entered a vessel. These includedetection techniques based on light, optics, pressure or sound. Thecomponents of the electronics and sensors 600 (FIG. 4) are modified asneeded to detect and determine bleed back based on the type of sensorused. FIG. 10A illustrates the movement of the components of theembodiment of FIG. 9 as an example of how this step of the method may beaccomplished.

Next according to step 330, advance a guide wire through a needle andinto a vessel. FIG. 11 illustrates the movement of the components of theembodiment of FIG. 9 as an example of how this step of the method may beaccomplished. Here, the guide wire advancement lever 14 has been moveddistally. This movement advances the guide wire 10 through the accessneedle lumen 23 and into the vessel 3. The guide wire tip 13 is roundedto allow for atraumatic advancement of the guide wire through and alongthe vessel 3.

Next according to step 340, advance a catheter 40 out of the housing 5along the guide wire 10 and into the vessel 3. FIG. 12 illustrates themovement of the components of the embodiment of FIG. 9 as an example ofhow this step of the method may be accomplished. Here, a user may graspthe catheter hub 45 and, while holding the device stationary, advancethe catheter 40 out of the housing 5 and into the vessel as shown. Notehow the slot 8 is sized to allow access to and passage of the catheterhub 45.

Next according to step 350, activate an automatic guide wire and/orneedle withdrawal mechanism. FIG. 13 illustrates the movement of thecomponents of the embodiment of FIG. 9 as an example of how this step ofthe method may be accomplished. Once the release button 30 is pressed,the biasing element 33 moves the guide wire and needle proximally asshown in FIG. 13. Note that the guide wire tip 13 is available forinspection through the housing distal end 7 (if the housing istransparent) or in any event by viewing the guide wire tip 13 though theslot 8.

FIG. 13 illustrates the automatic withdrawal of the needle and guidewire. Optionally, the needle and guide wire may be manually withdrawnfrom the vessel and into the device housing. The device in FIG. 34 is anexample of an insertion device configured for manual withdrawal.

Next according to step 360, separate the housing 6 and the catheter 40.FIG. 14 illustrates the result of separation of the catheter 40 and thedevice body 5. FIG. 14 shows the tip of the catheter 42 in the vessel 3and the catheter hub 45 on the patient's skin 2. The device housingappears as in FIG. 13 with the change that the catheter 40 is removedfrom the housing distal end 7.

Next according to step 370, inspect the guide wire tip 13. The guidewire tip 13 is visible in the distal end of the housing 7. This allowsthe guide wire tip 13 to be inspected as described in step 370. FIG. 13illustrates one embodiment of a catheter insertion device that providesfor guide wire tip 13 inspection, if such inspection is required orrecommended.

Some regulatory authorities may require inspection of the guide wire 10after use in the body. The embodiments of FIGS. 13, 19, 23A, 28A, 37A,and 40 each provide for inspection of the guide wire 10 after use in thebody. Additionally, the housing and other components that are near orenvelope the guidewire 10 may be made from clear medical grade or othersuitable plastics. In this way, the catheter insertion device mayoperate normally but because the components around the guide wire areclear, the guide wire inspection may precede unimpeded. Other guidewiretip inspection devices are described below, for example, in FIGS.43A-44F.

Returning briefly to the method described in flow chart 105 of FIG. 5.The steps of advancing and retracting the guide wire and the needle maybe automated. FIG. 15 illustrates an embodiment of a catheter insertiondevice where all the steps 130, 140 and 150 are provided for automation.While the embodiment of FIG. 15 illustrates the automation of all ofthese steps, other embodiments of the catheter insertion device of theinvention may include automation of one or more of the steps 130, 140and/or 150. For example, the catheter insertion device in FIG. 1illustrates a spring retraction device to automate the needle andguidewire (step 150) but provides for only manual insertion of theguidewire and catheter (steps 130 and 140). The various steps may beautomated or performed manually as the situation and design dictate. Oneof ordinary skill will appreciate that the various alternative manualand automated embodiments may be recombined in any number of differentconfigurations within the scope of the present invention.

FIG. 15 is a section view of FIG. 15 is an insertion device 1 b that issimilar to insertion device 1 a with the addition of both a guide wireadvancement mechanism 55 and a catheter advancement mechanism 60. Whileboth are illustrated in this exemplary embodiment, it is to beappreciated that either advancement mechanism or no advancementmechanism may be used in an insertion device. The guide wire advancementmechanism 55 includes a hinge 56, a motor 57 and rollers 58. Thecatheter advancement mechanism 60 includes a hinge 61, a motor 62 androllers 63. The insertion device 1 b also includes a blood sensor 50 andan indicator 51. Here, the sensor 50 and or the indicator 51 may be usedto trigger operation of the guide wire 55 or catheter 60 insertiondevices. Additionally, signaling from the guide wire insertion devicemay be used to trigger the operation of the catheter insertion device. Atrigger such as range of motion indicating that the guide wire iscompletely inserted or a motion detector or other trip, such as a reedswitch, to indicate that guide wire motion is complete or hindered mayalso be an input to the catheter advancement device.

One method for inserting a catheter 40 using insertion device 1 b willbe described with reference to FIGS. 16-19. The insertion technique issimilar to that described above with reference to FIGS. 10-14.

FIG. 16 illustrates the needle 20 puncturing the vessel 3. The sensor 50will detect the presence of blood 4 and the indicator 51 will inform theuser of the presence of blood 4 in the needle lumen 23. Once theindicator 51 is activated, the user is informed of the successful vesselpuncture.

FIG. 17 illustrates an automated version of step 130 in method 105 (FIG.5). Here, the sensor 50 is used to also activate the operation of theguide wire advancement motor 57. Operation of the guide wire advancementmotor 57 causes rotation of the rollers 58. Rotation of the rollers 58causes the guide wire 10 to move from within the needle lumen 23 andinto the vessel 3. The final position of the guidewire 10 and guide wiretip 13 after operation of the guide wire advancement motor 57 is shownin FIG. 17.

The guide wire advance motor 57 may cease operation by any of a numberof conventional techniques for monitoring the operation of a motor ormovement of an object. An encoder may be used to count the number ofrotations of the motor 57, the rollers 58, a lead switch may interruptoperation of the motor once the guide wire carrier has moved beyond acertain point, or an obstruction may be positioned within the housingthat, when contacted by the guide wire or the guide wire carrier causesthe guide wire advancement motor to cease operation.

Additionally, any of a number of strain or resistance gauges could becoupled to the guide wire, a guide wire component, the catheter, acatheter component or into a position on or in the housing in order toprovide an indication of when the guide wire and/or catheter has struckan obstruction or otherwise ceased unobstructed movement through thevessel 3. These are merely exemplary of any of a wide variety ofconventional sensing and detection means that may be coupled to theguide wire or the catheter or their carriers to assist in determiningmovement, range of movement or unobstructed movement. The output of theresistance sensing or detection means may be used as in input to theinsertion control system used to control the operation of the guide wireadvancement device or the catheter advancement device or even to monitorinsertion controlled by a user to ensure the user receives feedback thatthe advancement is not unobstructed or that resistance to insertion inincreasing.

In other aspects, the method of introducing a catheter a guide wire intoa vessel also include the step of stopping the propelling step when aninsertion resistance detector indicates that a detected resistance tocatheter advancement exceeds an allowable limit. Optionally, thesemethods may include stopping the propelling step when a resistance tocatheter or guide wire advancement is greater than a force used topropel the catheter or guide wire. This refers to the low force or lowspeed alternatives described below that use pneumatic, low forcesprings, shape memory alloy activated components or other suitable lowforce/low power advancement alternatives such as the motors selected forthe guide wire and catheter advancement devices. In other alternatives,the force used to propel the catheter or the guide wire is a springforce, a pneumatic force, a force generated by a motor or a forcegenerated by the movement or activation of a shape memory alloy element.

In another alternative, an insertion resistance detector is positionedon or in the device housing and is adapted to monitor the operation ofthe guide wire advancement device. Similarly, such a resistance detectormay be positioned on or in the device housing and adapted to monitor theoperation of the catheter advancement device.

FIG. 18 illustrates an automated version of step 140 in method 105 (FIG.5). Here, the sensor 50 may also used to also activate the operation ofthe catheter hub advancement motor 62. Alternatively, the catheteradvancement mechanism may be separately actuated by a user or as aresult of a trigger provided by a control system of received from theguide wire advancement mechanism or a system controlling the guide wireadvancement. Operation of the catheter hub advancement motor 62 causesrotation of the rollers 63. Rotation of the rollers 63 causes thecatheter 50 to move from within the distal end of housing 7 and into thevessel 3. The final position of the catheter 40 after operation of thecatheter hub advancement motor 62 is shown in FIG. 18. Note how thehinge 61 allows deflection of the catheter advance mechanism 60 todeflect in response to contact with the catheter hub 45. This deflectionmay be a trigger to cease operation of the motor 62.

The catheter advance motor 62 may cease operation by any of a number ofconventional techniques for monitoring the operation of a motor ormovement of an object. An encoder may be used to count the number ofrotations of the motor or the rollers 63, a lead switch may interruptoperation of the motor once the catheter 40 has moved beyond a certainpoint, or an obstruction may be positioned within the housing that, whencontacted by the catheter causes the catheter advancement motor 62 tocease operation. Deflection of the hinge 56, 61 may be used as a signalto cease operation of a motor or other advancement device.

Additionally, any of a number of strain or resistance gauges could becoupled to the catheter to provide an indication of when the catheterhas struck an obstruction or otherwise ceased unobstructed movementthrough the vessel 3. These are merely exemplary conventional sensingand detection means that may be coupled to the catheter to assist indetermining catheter movement or range of movement. The output of thesensing or detection means may be used as in input to the insertioncontrol system used to control the operation of the catheter advancementdevice.

FIG. 19 illustrates a version of step 150 in method 105 (FIG. 5). Here,the user moves the release 30 to also allow the spring or other biasingelement 33 to withdraw the needle 20 and the guide wire 10 out of thevessel 3 and catheter 40. As shown in FIG. 19 the guide tip 13 is alsovisible in the distal end 7 or via slot 8 to allow for easy inspection,if needed. Thereafter, the catheter 40 is removed from housing 5 andsecured to the patient as shown in FIG. 14 and in accordance with step160 (FIG. 5).

Automated advancement and withdrawal of components may be accomplishedusing any suitable technique such as the motors, springs or biasingmembers described herein. Additionally, pneumatic systems may be used toadvance, withdraw or otherwise move components of the catheter deliverysystems described herein. For purposes of illustration, the followingexamples are described with regard to one component. It is to beappreciated that these alternative actuation techniques may be appliedto the assisted or automated movement of any component in the device.

FIGS. 20A and 20B illustrate a catheter advancement device having apneumatically actuated guide wire advancement component. As shown inFIGS. 20A and 20B the housing proximal end 6 modified to include arecess 170 shaped to receive the pneumatic source 171. The pneumaticsource 171 could be any conventional container of compressed gas. Therecess in shaped to provide a friction fit for the pneumatic source 171into the housing 5. The pneumatic pathway 177 provides communicationbetween the recess 170 and the plunger 172. The pneumatic pathway maytake on any of a variety of shapes and dimensions to allow the releaseof compressed gas in the source 171 to move the plunger 172 to provide alow force or controlled movement of the guide wire 10. The guide wirecarrier 15 has been modified to include a plunger 172. The housing issized to provide a fluid tight fit between the plunger 172 and theinterior of the housing.

FIG. 20B illustrates the pneumatic source in use to move the plunger172. When the pneumatic source 171 is moved as indicated by the arrowand into contact with the puncture tip 173, the contents of the source171 are released into the pneumatic pathway 177 and push the plunger172. Movement of the plunger 172 moves the guide wire in the directionof the arrow (into a vessel).

FIGS. 21A and 21B illustrate a catheter advancement device havinganother pneumatically actuated guide wire advancement component.

Similar to FIGS. 20A and 20B, the pneumatic source 171 is used toprovide controlled, low force movement of the plunger 172 that in turnmoves the guide wire into a vessel. As shown in FIGS. 21A and 21B thehousing proximal end 6 modified to include a recess 170 shaped toreceive the pneumatic source 171. In contrast to the embodiment above,the pneumatic pathway 172 includes a flap or restrictor 174 to furthercontrol the release of the contents of the pneumatic source 171 throughthe pneumatic pathway 171. As shown here, the pneumatic pathway may takeon any of a variety of shapes and dimensions to allow the release ofcompressed gas in the source 171 to move interact with the restrictor174 and move the plunger 172 to provide a low force or controlledmovement of the guide wire 10.

FIG. 21B illustrates the pneumatic source in use to move the plunger172. When the pneumatic source 172 is moved as indicated by the arrowand into contact with the puncture tip 173, the contents of the source171 are released into the pneumatic pathway 172, past the restrictor 174and push the plunger 172. Movement of the plunger 172 moves the guidewire in the direction of the arrow (into a vessel).

FIGS. 22A and 22B illustrate a catheter advancement device having aguide wire advancement component that utilizes shape memory alloy (SMA)element or elements to facilitate guidewire movement. Housing proximalend 6 modified to include a shape memory alloy guide wire 10 a and theproximal end 12 attached within the housing proximal end 6. The wire 10a is attached to the guide wire carrier 15 (not shown).

For clarity, a conventional shape memory alloy power supply andcontroller are not shown. The components may be on, in or separate fromthe insertion device housing. A conventional power source is attached tothe SMA guide wire. Once activated, the SMA guide wire 10 a is used toadvance the guidewire carrier 15 along the housing and to push the guidewire tip 13 into a vessel (movement indicated by the arrow in FIG. 22B).It is to be appreciated that the SMA activation properties can becontrolled to minimize the speed or otherwise provide a low forceadvancement of the guide wire. Additionally, circuitry and suitableelectrical connections may be provided to the SMA controller that willcut power to the SMA guide wire 10 a in the event that friction or anobstruction is encountered that may indicate that the guide wire is notadvancing normally though the vessel.

While the pneumatic and shape memory alloy devices have been describedfor the movement of a guidewire, the invention is not so limited. Thesealternative advancement techniques may also be used for the advancementof a catheter or other moveable component as described herein. Forexample, the SMA element in FIGS. 22A and 22B may be replaces by a lowforce spring to advance the guide wire or otherwise configured toadvance the catheter. A low force spring in this context as well as thelow force of the other advancement modes is a force that is low enoughto provide the desired movement of the catheter or guide wire. However,as a safety precaution, the force generated is low enough that if itencounters increasing resistance (for example if the component hits anobstruction in a vessel or is misdirected into a vessel wall) then thedevice movement will cease. In some aspects, when such resistance isencountered or detected, an alarm or other indication of resistance,similar to those used for blood detection, may be provided to the useror the control system.

FIG. 23A illustrates an insertion device 1 c adapted to provide blooddraw capabilities. The blood draw device 1 c is similar to the device 1b of FIG. 9. Unlike the embodiment illustrated in FIG. 9, the embodimentof FIG. 23A includes several components and reconfiguration of existingcomponents to provide blood draw capabilities. Additionally, the portionof the housing 5 in the vicinity of the blood draw port 180 has beenmodified to accommodate the additional requirements of drawing blood.

Because the blood draw device includes blood sensing capabilities, theoperation and use of the blood draw device 1 c is similar to the stepsdescribed above with regard to FIGS. 10-13.

FIG. 23A is a section view of an apparatus for drawing blood. The blooddraw apparatus 1 c has many components in common with previouslydescribed insertion devices 1, 1 a and 1 b. The blood draw apparatus 1 cincludes a housing 5 having a proximal end 6, a distal end 7 and aninterior volume 9. A seal 186 within the housing 5 partitions theinterior volume 9 into a first interior volume portion 9 a and a secondinterior volume portion 9 b. A housing lumen 9 c extends from thehousing distal end 7 and is in communication with the first interiorvolume portion 9 a. The apparatus 1 c also includes a view port 185 forinspection of the guide wire tip 13. The housing distal end 7 has a nosesection 7 a. The nose section 7 a has a lumen and interior volumeconfigured to fit over the flexible tube 195.

There is also provided a blood draw port 180 on the housing 5 incommunication with the first interior volume portion 9 a. The blood drawport 180 includes a fixture 181 to receive a blood draw container 182. Aseal 183 may also be provided in the blood draw port or to maintain afluid tight seal with blood containers or other devices to facilitateblood sampling. A hollow member 184 is also shown within the port 180.The hollow member 184 may have a sharp end to penetrate the seal of ablood draw container (see FIG. 28A).

The blood draw apparatus 1 c also includes a flexible tube advancementhandle 190. The flexible tube advancement handle 190 includes a lever191 with an end 192 shaped to engage with the proximal end 197 of theflexible tube 195 and or the flexible tube seal 199. The flexible tube195 has a distal end 196, a proximal end 197 and a flexible tube lumen198. There is also a flexible tube seal 199 provided about the exteriorof the flexible tube 195 to seal the flexible tube 195 within the nosesection 7 a.

Similar to the description above of the other devices, the blood drawdevice includes an access needle 20 extending through the housing lumen.The access needle 20 has an access needle lumen 23. The access needle 20has a distal end that extends beyond the housing distal end, and aproximal end within the second interior volume portion 9 b. As before,there is a guidewire 10 within the access needle lumen 23.

Other components in common with other devices include, for example,guide wire carrier 15, biasing element 33, release 30, guide wire lever31, blood sensor 50 and indicator 51.

FIG. 24A illustrates the blood draw device 1 c during a conventionalneedle stick into a vessel 3 as described above and shown in FIG. 10.FIG. 24B, like FIG. 10A illustrates the detection of blood 4 within theneedle lumen 23 and activation of the indicator 51. FIG. 25, like FIG.11, illustrates the advancement of the guide wire tip 13 into the vessel3. FIG. 26 illustrates the advancement of the flexible tube 195 into thevessel 3 in much the same way as the catheter advancement shown in FIG.12 inserts the catheter into the vessel 3. The main difference here isthat the flexible tube advancement handle 190 is provided for the distalmovement of the flexible tube 195.

With the flexible tube 195 within the vessel 3, the guide wire 10 andneedle 20 may be withdrawn from the flexible tube 195 and the vessel 3by activation of the release 30 (FIG. 27). Note that the needle 20 andthe guide wire 10 are withdrawn to position a proximal to the seal 183.In this position, the needle 20 and the guide wire 10 are both withinthe second internal volume portion 9 b. The flexible tube 195 nowprovides a fluid conduit from the vessel to the blood draw port 180.

Note that the guide wire tip 13 is visible in the view window 185. Thehousing may be formed from a clear, medical grade plastic that allowsfor easy inspection of the guide wire tip 13 if needed. The seal 186closes once the needle 20 and guide wire 10 are withdrawn proximallyinto the housing 5. The seal 186 helps keep the blood within the housingnear the blood sample port and the housing distal end.

FIG. 28A also shows the seal 186. The seal 186 allows the guide wire 10and needle 20 to pass through as shown in FIG. 23A. When the guide wireand needle are withdrawn from the vessel (FIG. 27), the seal 186 closesand prevents blood from filling the proximal end of the housing. Theneedle and guidewire are withdrawn beyond it and it seals.

FIG. 28A illustrates how a blood draw container 182 and be placed on theblood draw port fixture 181. In this position, the hollow member 184penetrates the seal 182 a thereby allowing blood to be drawn into thecontainer 182. When blood sampling is completed, the handle 190 is movedproximally thereby withdrawing the flexible tube 195 from the vessel 3and into the nose section 7 a. When the blood collection is completed,the device 1 c is discarded.

Several alternative seal 186 designs are possible. FIGS. 28B and 28Cillustrate a flap type seal where the flaps are distal facing (FIG. 28B)or proximal facing (FIG. 28C). In either orientation, the seals providea blood tight seal around the needle during catheter insertionoperations and then provide a blood tight seal within the housing oncethe needle and guidewire are withdrawn into the proximal end of thehousing. It is to be appreciated that the various alternative sealembodiments in FIGS. 29A-33B and other seal embodiments described hereinmay be modified to provide distal facing or proximal facing sealingcapabilities.

The seal 186 used to provide separation of the housing interior volumesmay be provided using any suitable seal. Numerous sealing devices andconfigurations may be used as exemplified by the seal embodiments ofFIGS. 28A-33B. The seal 186 and the alternatives described below areformed from a suitable flexible material such as rubber, silicone, orother medical grade elastomer that forms a suitable barrier to thepassage of blood.

FIGS. 28B and 28C illustrate a seal 250 as an alternative embodiment tothe seal 186. The seal 250 has flaps 250 a and 250 b. FIG. 28A is anembodiment where the flaps 250 a, 250 b are configured to draw togetherdistally when the access needle 20 is withdrawn. FIG. 28C is anembodiment where the flaps 250 a and 250 b are configured to drawtogether proximally when the access needle 20 is withdrawn.

FIGS. 29A and 29B illustrate a sealing element 254 as an alternativeembodiment to the seal 186. The sealing element 254 is attached to abase 251 that is configured to support the sealing element 254. The base251 is sized to fit within the housing 5 and facilitate the use ofsealing element 254 within the housing 5. The base 251 is used to mountthe sealing element 254 within the housing to provide sealingcapabilities like the seal 186 (see FIG. 27). The sealing element 254has a nipple shape with an aperture 252. FIG. 29A illustrates thesealing configuration when the needle 20 is in use as in FIG. 26. Whenthe needle 20 is in use, the aperture 252 forms a seal around the needle20. FIG. 29B illustrates the sealing configuration of the sealingelement 254 when the needle 20 is withdrawn into the housing. When theneedle 20 is withdrawn proximal to the sealing element 254, the aperture252 closes to function similar to seal 186 in FIG. 27.

FIGS. 30A and 30B illustrate a sealing element 256 as an alternativeembodiment to the seal 186. The sealing element 256 is attached to abase 251 that is configured to support the sealing element 256. The base251 is sized to fit within the housing 5 and facilitate the use ofsealing element 256 within the housing 5. The base 251 is used to mountthe sealing element 256 within the housing to provide sealingcapabilities like the seal 186 (see FIG. 27). The sealing element 256has a funnel shape with an aperture 252. FIG. 30A illustrates thesealing configuration when the needle 20 is in use as in FIG. 26. Whenthe needle 20 is in use, the aperture 252 forms a seal around the needle20. FIG. 30B illustrates the sealing configuration of the sealingelement 256 when the needle 20 is withdrawn into the housing. When theneedle 20 is withdrawn proximal to the sealing element 256, the aperture252 closes to function similar to seal 186 in FIG. 27.

FIGS. 31A and 31B illustrate a sealing element 258 as an alternativeembodiment to the seal 186. The sealing element 258 is separated intotwo parts 258 a and 258 b. The sealing element 258 is attached to a base251 that is configured to support the sealing element 258. The base 251is sized to fit within the housing 5 and facilitate the use of sealingelement 258 within the housing 5. The base 251 is used to mount thesealing element 258 within the housing to provide sealing capabilitieslike the seal 186 (see FIG. 27). The sealing element parts 258 a, 258 bhave a funnel shape and are biased together to form an aperture 252similar to the sealing element 256. FIG. 31A illustrates the sealingconfiguration when the needle 20 is in use as in FIG. 26. When theneedle 20 is in use, the parts 258 a, 258 b form an aperture 252 thatseals around the needle 20. FIG. 31B illustrates the sealingconfiguration of the sealing element 258 when the needle 20 is withdrawninto the housing. When the needle 20 is withdrawn proximal to thesealing element 258, the parts 258 a, 258 b draw together to close theaperture 252 to function similar to seal 186 in FIG. 27.

FIGS. 32A and 32B illustrate a sealing element 260 as an alternativeembodiment to the seal 186. The sealing element 260 is separated intotwo parts 260 a and 260 b. The sealing element 260 is attached to a base251 that is configured to support the sealing element 260. The base 251is sized to fit within the housing 5 and facilitate the use of sealingelement 258 within the housing 5. The base 251 is used to mount thesealing element 260 within the housing to provide sealing capabilitieslike the seal 186 (see FIG. 27). The sealing element parts 260 a, 260 bhave a flat shape like a duck bill and are biased together to form anaperture 252 similar to the sealing element 258. FIG. 32A illustratesthe sealing configuration when the needle 20 is in use as in FIG. 26.When the needle 20 is in use, the parts 260 a, 260 b form an aperture252 that seals around the needle 20. FIG. 32B illustrates the sealingconfiguration of the sealing element 258 when the needle 20 is withdrawninto the housing. When the needle 20 is withdrawn proximal to thesealing element 260, the parts 260 a, 260 b draw together to close theaperture 252 to function similar to seal 186 in FIG. 27.

FIGS. 33A and 33B illustrate a sealing element 262 as an alternativeembodiment to the seal 186. The sealing element 262 is attached to abase 251 that is configured to support the sealing element 262. The base251 is sized to fit within the housing 5 and facilitate the use ofsealing element 262 within the housing 5. The base 251 is used to mountthe sealing element 262 within the housing to provide sealingcapabilities like the seal 186 (see FIG. 27). The sealing element 262has an elongated tube 263 shape with an aperture 252 on the end of thetube 263. FIG. 33A illustrates the sealing configuration when the needle20 is in use as in FIG. 26. When the needle 20 is in use, the aperture252 forms a seal around the needle 20. FIG. 33B illustrates the sealingconfiguration of the sealing element 262 when the needle 20 is withdrawninto the housing. When the needle 20 is withdrawn proximal to thesealing element 262, the tube 263 collapses closing the aperture 252thereby functioning similar to seal 186 in FIG. 27.

FIG. 34 illustrates a manual withdrawal blood draw device similar to theblood draw device illustrated and described in FIG. 23A. Unlike theembodiment of FIG. 23A, the blood draw device embodiment of FIG. 34 doesnot include any automatic guidewire withdrawal capabilities. Instead,the guide wire 10 is withdrawn by moving the guide wire handle 14proximally until the guide wire tip 13 is visible proximal of the seal186. The guide wire tip 13 may be visible in the view port 185.Similarly, the biasing element 33 has been replaced by a needlewithdrawal handle 270 with a latch 272 having a fitting 273 that engageswith the needle boss 24. Movement of the handle 270 moves the needlecarrier 25 and in turn the needle 20.

FIG. 35 illustrates an alternative blood draw port 180 similar to thatshown in FIG. 23A. Here, the hollow member 184 has been replaced by apuncture seal 183 a. The puncture seal 183 a allows for the use of asyringe and needle to penetrate the seal 183 a to draw off a bloodsample. This seal 183 a is a suitable porous rubber or other materialthat would allow a user to inset a needle through the seal 183 a andwithdraw a sample from within the housing in the blood draw area.

FIG. 36 illustrates another alternative blood draw port 180 that isconnected to a blood draw apparatus or fixture 292. The tubing 290 andthe blood draw device 292 could be any convention blood draw device orother phlebotomy equipment. Here the blood draw fixture is modified intofixture 183 a that seals with or receives the tubing 290. In this way,the blood draw device 292 is in communication with the interior volumeto draw blood.

In contrast to the rigid housing tip and flexible tube used in FIG. 23A,there are also blood draw devices of the present invention that providea flexible distal end. FIGS. 37A-42 illustrate an embodiment of one suchflexible tip blood draw device 1 d. As illustrated in the figures thatfollow, a pair of flexible tubes may be used to provide a flexible tipto the blood draw device.

FIG. 37A illustrates a section view of a blood draw device 1 d. Theblood draw device is similar to previous devices, such as thatillustrated in FIG. 23A, and common references numbers are used.

FIG. 37A is an alternative of FIG. 23A where a flexible tube replacesthe rigid distal end of the housing. In contrast to earlier embodiments,the flexible tube 195 is within an outer flexible tube 195 rather thanthe distal end of the housing. The flexible tube 195 has a distal end196, a proximal end 197 and a flexible tube lumen 198. The proximal end197 is sealed within housing 5 so that the lumen 198 is in communicationwith the first interior volume 9 a. The outer flexible tube 380 includesan outer flexible tube distal end 381 and an outer flexible tubeproximal end 382. The proximal end 382 may include a luer fitting, valveor a seal 386 held open while the inner flexible tube 195 is present.There is also an outer flexible tube lumen 383 that runs from theproximal end 382 to the distal end 381. Optionally, one or more flaps384 are provided to secure or handle the outer flexible tube 380. In oneembodiment, the outer flexible tube 380 is similar in construction to acatheter 40 described above.

As with other embodiments, there is provided an access needle 20, aguide wire 10, sensor 50, an indicator 51 and other similar components.As with other embodiments, the guide wire 10 is within the access needlelumen 23. The access needle 20 is within the lumens of the flexibletubes 195, 380. The flexible tube 195 is within the outer flexible tubelumen 198.

FIG. 37A illustrates the needle entering the vessel 3 and an indicationof bleed back as discussed above. Next, FIG. 38 illustrates theadvancement of the guide wire tip 13 into the vessel 3.

FIG. 39 illustrates the advancement of the outer flexible tube 380 alongthe guide wire 10 and into the vessel 3. Note that the needle 10 is usedto provide rigidity to allow the sliding of the tubes without kinkingAdditionally, the outer tubing lumen 383 is sized to accommodate andslide along the outer wall of the inner tubing 195. The seal 386maintains a seal between the flexible tubes.

FIG. 40 illustrates the withdrawal of the needle 20 and guide wire 10 asdescribed above. Once the needle is removed, the flexible tubes providefluid communication from the vessel 3 into the first interior volume 9a. One completed, the port 180 may now be used to draw blood asdescribed above and shown in FIG. 41.

FIG. 42 illustrates the outer flexible tube remaining behind aftercompletion of the blood draw. The outer tube may be a catheter hub witha seal or port on the proximal end. The seal or port 386 is held open bythe inner flexible tube 195. Once the inner flexible tube 195 isremoved, the seal 386 closes. The flexible tube device 380 could be usedduring hospital admissions for initial blood draw and then remain inplace for use as an intravenous catheter. Also the device of FIG. 23Acould be modified to accept a catheter 40 or hub 43 in the distal end ofthe housing, such as illustrated above. In this way, the placement ofthe flexible tube or cannula 380 for a blood draw is subsequently usedas a catheter for further treatment of the patient.

FIG. 43A-43C shows another form of mechanical stop to allow forinspection of the guidewire tip. This housing 5 includes a shaped slot390 that hinders the movement of the guide wire handle 14 to facilitateinspection of the guide wire tip 13. The shaped slot 390 has a proximalportion 392 and a distal portion 393. A notch 394 is position proximalto the distal portion 392. A by pass 395 allows movement of the guidewire handle 14 beyond the notch 394 and to proceed into the proximalslot portion 393.

FIG. 44A-44F illustrate another alternative venous access device thatprovides a mechanical stop to facilitate inspection of the guide wiretip 13. Insertion device 1 d is shown during an insertion processsimilar to those devices above. At this point, the catheter advancementlever 550 has advanced the intravenous catheter 40 along slot 8 in thedistal end of housing 5. The guidewire tip 13 and the catheter distalend 42 are visible in the vessel 3. The insertion device includes ableed back notch 501 in the access needle 20. A needle stop 505 ispositioned within the housing interior space 9 to support the needlecarrier 25 and hold the bias element 33 in compression against therelease button 30. The guide wire lever 14 and guide wire carrier 15 areshown in a distal most position against the guide wire stop 510. Theguide wire stop 510 can be used to stop distal advancement of the guidewire carrier 15 so that the guide wire carrier does not interfere withthe position of the release button 30 or the needle carrier boss 24.Additionally, as best seen in FIG. 44E, the height of the guide wirestop 510 and the proximal wedge 540 are selected to prevent the distalmovement of the post fracture inspection stop 515.

Returning to FIG. 44A, the guide wire carrier 15 also includes aninspection stop 515. The inspection stop 515 includes a fracture point520 and a tip 525. The fracture point 520 is positioned to allow the tip525 to break away from the inspection stop 515. The insertion device 1 dalso includes a housing stop 530. The housing stop 530 includes a distalwedge 535 and a proximal wedge 540. The distal wedge 535 is sized andpositioned to interact with and cause the fracture of the tip 525. Thesize and shape of the proximal wedge 540 is intended to prevent thedistal movement of the guide wire carrier once the carrier has movedinto a position proximal to the proximal wedge 540 (see FIG. 44F).

The operation of the insertion device 1 d to permit guide wire tipinspection will now be described. FIG. 44A illustrates the insertiondevice 1 d at the point of catheter insertion just before withdrawal ofthe guide wire 10 and access needle 20. FIG. 44B illustrates theautomatic withdrawal of the guide wire 10 and access needle 20 bylifting/operating the release button 30. After the biasing element 33expands, the guide wire carrier 15 is moves proximally until the tip 525contacts the distal wedge 535. At this point, the catheter 40 is removedfrom the housing 1 d and attached to the patient. FIG. 44C illustratesthe insertion device 1 d once the catheter 40 is removed. FIG. 44D is abottom up view of the device 1 d shown in FIG. 44C. FIG. 44D illustratesthat while the inspection stop 515 remains in contact with the distalwedge 535, the guide wire tip 13 and, optionally, the access needle tip21 are visible in housing distal end 7 within the interior volume 9 asis with the catheter. FIG. 44D illustrates the insertion device 1 d oncethe guide wire tip inspection is complete.

After inspecting the guide wire tip 13, a user may advance the guidewire carrier 15 proximally. The proximal movement of the guide wirecarrier 15 urges the inspection stop 515 against the distal wedge 525until the tip 525 separates from the inspection stop 515 along thefracture point 520. Thereafter, the guide wire carrier 15 movesproximally beyond the proximal wedge 540. The proximal movement of theguide wire carrier 15 withdraws the access needle 20 and the guide wiretip 13 into the housing interior space 9 (FIGS. 44E and 44F).

While many of the above embodiments are illustrated and described with acatheter 40 having a hub or wings 43, embodiments of the presentinvention are not so limited. Any style catheter may be used with theinsertion and blood draw devices described herein. Catheters withouthubs or wings or butterfly style catheters may also be used with thedevices and techniques described herein.

What is claimed is:
 1. A catheter insertion device, comprising: ahousing; a needle having a proximal end positioned in the housing and adistal end extending beyond a distal end of the housing; a catheterpositioned coaxially over the needle, the catheter comprising a flexibletube and a catheter hub on a proximal end of the flexible tube, whereina proximal portion of the flexible tube and the catheter hub arepositioned in the housing; a guide wire having a proximal end positionedin the housing and a distal end positioned in a lumen of the needle; anda handle coupled to the catheter, wherein movement of the handlerelative to the housing moves the catheter hub from a position in thehousing to a position outside of the housing.
 2. The catheter insertiondevice according to claim 1, further comprising a guide wire advancementmember, wherein movement of the guide wire advancement member moves theguide wire relative to the needle.
 3. The catheter insertion deviceaccording to claim 2, wherein the guide wire advancement member includesa guide wire carrier associated with the guide wire in the housing. 4.The catheter insertion device according to claim 2, wherein movement ofthe guide wire advancement member is initiated by a user.
 5. Thecatheter insertion device according to claim 1, wherein the guide wiredistal end comprises a coiled tip.
 6. The catheter insertion deviceaccording to claim 1, wherein a distal end of the flexible tube extendsbeyond a distal end of the housing prior to movement of the catheter hubto the position outside of the housing.
 7. The catheter insertion deviceaccording to claim 1, wherein movement of the handle is initiated by auser.
 8. The catheter insertion device according to claim 1, furthercomprising a seal at a proximal end of the catheter hub.